www.fdanews.com/articles/183630-mazor-robotics-snags-ce-mark-for-surgical-platform
Mazor Robotics Snags CE Mark for Surgical Platform
September 21, 2017
Mazor Robotics, a Caesarea, Israel-based manufacturer of surgical robotic systems, announced it has received CE Mark approval for its Mazor X Surgical Assurance Platform.
The platform, which received 510(k) clearance as a Class II device in 2015, is a guidance system for spine surgery with 3-D planning tools, precision mechanics pre-op analytics software, and intraoperative surgical arm verification.
Mazor X will be marketed and sold in Europe by the company’s commercial partner Medtronic.